Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML

Inclusion Criteria:

1. ≥18 years and ≤75 years in age

2. AML diagnosed with ≥20% myeloid marrow blasts or peripheral blood blasts per WHOcriteria(2008) at the time of initial diagnosis

3. For subjects with primary refractory AML:

4. Refractory disease is defined as persistent disease (≥5% blasts in the bonemarrow) at least 28 days after initiation of anthracycline-containing inductiontherapy or relapse from a first remission (CR, CRi, complete remission withincomplete platelet recovery [CRp], CRh) lasting for <90 days. Isolatedextramedullary disease is not allowed.

5. Persistent disease (≥5% blasts in the bone marrow): Must have received 1 (andonly 1) prior anthracycline-containing induction regimen. Except as definedbelow, a second induction with intent to induce remission is not allowed.

6. Re-induction within 28 days with a comparable regimen containing the samechemotherapy agents (e.g., cytarabine/daunorubicin '7+3' and '5+2'; orcytarabine/daunorubicin '7+3' and '7+3') is allowed.

7. Re-induction within 28 days with a comparable regimen using an alternativeanthracycline (e.g., cytarabine/daunorubicin in the first induction andcytarabine/idarubicin in the second) is allowed.

8. Previous induction with certain regimens (venetoclax/hypomethylating agent [HMA], venetoclax/LDAC, single agent HMA) followed by an anthracyclineinduction regimen is allowed. May have achieved remission with certainregimens (venetoclax/HMA, venetoclax/LDAC, single agent HMA) and thenexperience relapse now refractory to anthracycline-containing induction.

9. Relapse from first remission (CR, CRi, CRp, CRh) lasting <90 days: 1) Afterachieving first remission from any induction regimen, may have receivedconsolidation before experiencing relapse.

10. No more than one prior stem cell transplant.

11. Has not received the chemotherapy regimen to be used for induction on this trial.

12. Is considered medically eligible to receive the chemotherapy regimen to be used forinduction on this trial.

13. Peripheral absolute blast count (ABC) ≤40.0 x 109/L (ABC = total white blood cells [WBC] x blast % in peripheral blood). Hydroxyurea to control absolute blast count isallowed prior to uproleselan/placebo dosing.

14. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia

2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)

3. Chronic myeloid leukemia with myeloid blast crisis

4. Active signs or symptoms of CNS involvement by malignancy (No lumbar puncturerequired)

5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

6. Allogeneic HSCT ≤ 4 months, autologous HSCT ≤ 3 months or donor lymphocyte infusion (DLI) ≤ 6 weeks prior to Uproleselan/placebo dosing.

7. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any otherexperimental therapy or chemotherapy within 14 days of dosing

8. Inadequate organ function.

9. Abnormal liver function.

10. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

11. Creatinine clearance <45 mL/min (Cockcroft-Gault method) or creatinine >1.5x ULN (any assessed must be within eligibility limit).

12. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

13. Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject hascurrent significant cardiovascular disease.

14. Major surgery within 4 weeks before uproleselan/placebo dosing.